Pine Brook, NJ

Labeling Associate II, Regulatory Affairs 

SUMMARY OF POSITION The Associate, Regulatory Labeling prepares, reviews and submits to his/her manager high-quality regulatory labeling submissions intended for the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. Submissions will include ANDAs, amendments, supplements, Annual Reports and advertising and promotion campaigns. This position researches and, under the direction of the Legal Team, prepares appropriate labeling carve-outs based on submission strategies. He/she provides guidance to teams and peers on labeling guidelines and works to solve increasingly complex labeling projects/problems. This individual is responsible for preparation of labeling in meeting regulatory submission timelines. He/she prepares, reviews and submits Structured Product Labeling to FDA and is responsible for Drug listing activities.

ORGANIZATION STRUCTURE The Associate, Regulatory Labeling reports into the Director Labeling and is based in Pine Brook, New Jersey.

RESPONSIBILITIES Primary responsibilities of this role include the following:

  1. With direction, prepares, reviews and submits high quality regulatory labeling submissions to the FDA via eCTD gateway.
  2. With supervision, prepares responses to labeling comments received from the US FDA.
  3. Serves as the PRC Chair and reviews, approves and submits advertising and promotional materials to the FDA under FDA form 2253.
  4. Attends project meetings, independently tracks FDA labeling changes and implements safety-labeling changes based on departmental work instructions.
  5. Participates in product team meetings and provides labeling support and guidance to internal and external customers.
  6. Reviews labeling change control requests for completeness and accuracy. Assesses the impact of the changes as they relate to approved ANDAs and/or NDAs and communicates the impact to his/her manager.
  7. Responsible for the accurate and timely preparation of all labeling components: physician insert, patient insert, carton label, bottle label, printed foils, transdermal patch backing, vials labels, etc.
  8. Responsible for the preparation, review and submission of SPL to the FDA.
  9. Manages Drug Listing activities.
  10. Work with print providers and external graphic services.

QUALIFICATIONS Minimum of a Bachelor’s Degree in a scientific discipline or English major. • Minimum of 5 years in the pharmaceutical industry with 2-3 of those years in regulatory affairs labeling.

Job-Specific Competencies/Skills: • Excellent verbal and written communication skills. • Highly motivated, results driven with unyielding predisposition to detail, accuracy and clarity. • Demonstrates in-depth knowledge and understanding of FDA guidelines with proven ability to successfully apply these to work output. • Performs duties with the highest ethical standards, delivering only high-quality, compliant submissions to FDA. • Strong critical and logical thinker with ability to analyze problems and recommend solutions. • Effectively communicates regulatory requirements and strategies as they affect regulatory submissions to internal and external partners. • Demonstrates a sound ability to make appropriate decisions on regulatory labeling activities and work outputs • Effectively prioritizes competing tasks in a fast-paced and dynamic environment. • Ad Promo experience preferred. • Knowledge of print process or graphics a plus.

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